Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients (MELCAYA)

This is a retrospective observational cohort study, the primary objective is investigate the activity and efficacy of anti PD-1 antibodies in children, adolescents and young adult melanoma patients, with radically resected or metastatic disease

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Melanoma; Early Melanoma

Detailed Description

The aim of the study is to evaluate the activity and efficacy of anti PD-1 antibodies in adolescent, childhood and young adult with early and advanced melanomas through a multicenter transnational European retrospective analysis Clinical outcomes will be retrospectively retrieved beginning from the primary diagnosis of melanoma. Clinical outcomes will be retrospectively evaluated starting from the time of start of treatment for up to a the most recent follow-up. Data collected will include demographic information, disease history, baseline conditions, clinical outcomes of interest.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Mario Mandala, MD; Phone Number: 00393386605619; Email: mario.mandala@unipg.it
• Study Contact Backup: Name: Roberta Matocci; Phone Number: +390755784099; Email: roberta.matocci@ospedale.perugia.it

Study Locations

• France
  • Marseille, France
    • Aix-Marseille Universite
  • Paris, France
    • Institut Curie
• Germany
  • Berlino, Germany
    • Ospedale universitario della Charité
  • Heidelberg, Germany
    • German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ)
  • Tuebingen, Germany
    • University Children's Hospital Tuebingen
• Italy
  • Firenze, Italy
    • Università degli studi di Firenze
  • Milano, Italy
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Roma, Italy
    • Universita Cattolica del Sacro Cuore
• Netherlands
  • Utrecht, Netherlands
    • Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie)
• Poland
  • Warsaw, Poland
    • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
• Spain
  • Barcellona, Spain
    • Institut Catala d'Oncologia
  • Barcellona, Spain
    • Instituto de Investigaciones Biomédicas August Pi i Sunyer
• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adolescent, childhood and young adult with early and advanced melanomas treated with anti PD-1 therapy

Description

Inclusion Criteria:

1. Patients of either sex aged ≥ 12 years;
2. Histologically confirmed melanoma;
3. Anti PD-1 Immunotherapy (Ipilimumab plus Nivolumab);
4. Previous and subsequent treatments will be collected;
5. Clinical and follow-up data available

Exclusion Criteria:

1. No immunotherapy received;
2. No melanoma;
3. Age > 30 yrs

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
adolescent/childhood; patients <20 years old with with stage III and IV melanoma diagnosis
young adult; patients < 30 years with stage III and IV melanoma diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of objective response	efficay of anti PD-1 antibodies in adolescent, childhood and young through Tumor assessment revision adult with early and advanced melanomas	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse event incidence	Number of AE occurred during treatment defined using CTCAE v5.0	12 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Perugia

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PD-1 antibodies, childhood, adolescent, melanoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 4504/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No